Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children (NCT NCT01196988)
NCT ID: NCT01196988
Last Updated: 2018-09-21
Results Overview
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3027 participants
Primary outcome timeframe
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Results posted on
2018-09-21
Participant Flow
Subjects were differentiated according to their priming status. Primed subjects had received at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine and had received 2 doses of seasonal influenza in the last season or had received at least 1 dose prior to last season. Unprimed subjects had not.
3015 subjects out of the 3027 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria. The treatment was stratified by age strata: 3-8 and 9-17 years. Another arm evaluates the GSK2321138A vaccine for children aged 6-17 and 18-35 months.
Participant milestones
| Measure |
GSK2321138A 1 Group
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
915
|
912
|
911
|
277
|
|
Overall Study
COMPLETED
|
891
|
880
|
886
|
276
|
|
Overall Study
NOT COMPLETED
|
24
|
32
|
25
|
1
|
Reasons for withdrawal
| Measure |
GSK2321138A 1 Group
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
16
|
29
|
21
|
1
|
|
Overall Study
Other
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children
Baseline characteristics by cohort
| Measure |
GSK2321138A 1 Group
n=915 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=912 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=911 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=277 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Total
n=3015 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
98.5 Months
STANDARD_DEVIATION 44.40 • n=5 Participants
|
98.2 Months
STANDARD_DEVIATION 45.50 • n=7 Participants
|
99.6 Months
STANDARD_DEVIATION 44.20 • n=5 Participants
|
22.1 Months
STANDARD_DEVIATION 8.02 • n=4 Participants
|
79.6 Months
STANDARD_DEVIATION 35.53 • n=21 Participants
|
|
Sex: Female, Male
Female
|
443 Participants
n=5 Participants
|
439 Participants
n=7 Participants
|
440 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
1440 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
472 Participants
n=5 Participants
|
473 Participants
n=7 Participants
|
471 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
1575 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Outcome measures
| Measure |
GSK2321138A 1 Group
n=791 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=819 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=801 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=234 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU A/Cal/7/09, PRE
|
21.6 titers
Interval 19.7 to 23.7
|
24.9 titers
Interval 22.8 to 27.3
|
22.1 titers
Interval 20.1 to 24.2
|
12.3 titers
Interval 10.2 to 14.8
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU B/Bri/3/07, PRE
|
77.3 titers
Interval 70.0 to 85.3
|
77.2 titers
Interval 70.0 to 85.2
|
84.7 titers
Interval 76.6 to 93.6
|
13.1 titers
Interval 11.4 to 15.2
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU A/Cal/7/09, POST
|
386.2 titers
Interval 357.3 to 417.4
|
433.2 titers
Interval 401.0 to 468.0
|
422.3 titers
Interval 390.5 to 456.5
|
140.0 titers
Interval 113.7 to 172.3
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU A/Vic/210/09, PRE
|
29.0 titers
Interval 26.6 to 31.6
|
31.4 titers
Interval 28.8 to 34.2
|
31.2 titers
Interval 28.6 to 34.2
|
8.6 titers
Interval 7.4 to 9.9
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU A/Vic/210/09, POST
|
228.8 titers
Interval 215.0 to 243.4
|
227.3 titers
Interval 213.3 to 242.3
|
234.0 titers
Interval 219.1 to 249.9
|
87.5 titers
Interval 73.8 to 103.7
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU B/Bri/60/08, PRE
|
30.9 titers
Interval 28.2 to 33.9
|
31.0 titers
Interval 28.2 to 34.0
|
33.2 titers
Interval 30.2 to 36.6
|
9.0 titers
Interval 7.9 to 10.4
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU B/Bri/60/08, POST
|
244.2 titers
Interval 227.5 to 262.1
|
245.6 titers
Interval 229.2 to 263.2
|
88.4 titers
Interval 81.5 to 95.8
|
86.4 titers
Interval 72.6 to 102.9
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU B/Bri/3/07, POST
|
569.6 titers
Interval 533.6 to 608.1
|
224.7 titers
Interval 207.9 to 242.9
|
643.3 titers
Interval 603.2 to 686.1
|
167.7 titers
Interval 144.1 to 195.3
|
PRIMARY outcome
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Outcome measures
| Measure |
GSK2321138A 1 Group
n=790 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=818 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=800 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=232 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
FLU A/California/7/09
|
722 Participants
|
735 Participants
|
733 Participants
|
181 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
FLU A/Victoria/210/09
|
571 Participants
|
578 Participants
|
575 Participants
|
159 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
FLU B/Brisbane/3/07
|
573 Participants
|
303 Participants
|
566 Participants
|
191 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
FLU B/Brisbane/60/08
|
553 Participants
|
560 Participants
|
237 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=791 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=819 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=801 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 9-17 years
|
204.1 titers
Interval 185.5 to 224.5
|
204.9 titers
Interval 185.4 to 226.6
|
217.5 titers
Interval 196.9 to 240.2
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 3-8 years
|
20.7 titers
Interval 18.3 to 23.3
|
22.2 titers
Interval 19.8 to 24.9
|
22.4 titers
Interval 19.8 to 25.3
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 3-8 years
|
353.4 titers
Interval 319.9 to 390.3
|
382.1 titers
Interval 345.4 to 422.7
|
381.3 titers
Interval 345.0 to 421.5
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 9-17 years
|
23.2 titers
Interval 20.2 to 26.6
|
30.2 titers
Interval 26.1 to 34.9
|
21.5 titers
Interval 18.6 to 24.8
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 9-17 years
|
445.8 titers
Interval 393.9 to 504.7
|
533.3 titers
Interval 474.9 to 599.0
|
502.0 titers
Interval 444.1 to 567.5
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 3-8 years
|
29.3 titers
Interval 26.1 to 32.9
|
32.9 titers
Interval 29.2 to 37.0
|
31.5 titers
Interval 28.0 to 35.5
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 3-8 years
|
245.5 titers
Interval 226.4 to 266.2
|
242.0 titers
Interval 222.9 to 262.8
|
244.4 titers
Interval 224.1 to 266.5
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 9-17 years
|
28.5 titers
Interval 25.1 to 32.3
|
29.0 titers
Interval 25.8 to 32.7
|
30.8 titers
Interval 27.0 to 35.1
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 3-8 years
|
27.1 titers
Interval 24.0 to 30.6
|
25.1 titers
Interval 22.3 to 28.3
|
27.9 titers
Interval 24.6 to 31.6
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 3-8 years
|
236.3 titers
Interval 215.4 to 259.2
|
222.3 titers
Interval 202.8 to 243.7
|
79.2 titers
Interval 71.2 to 88.2
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 9-17 years
|
38.3 titers
Interval 33.4 to 43.9
|
43.9 titers
Interval 38.2 to 50.6
|
44.7 titers
Interval 38.6 to 51.7
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 9-17 years
|
257.5 titers
Interval 230.7 to 287.5
|
289.8 titers
Interval 262.1 to 320.4
|
106.4 titers
Interval 94.6 to 119.8
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 3-8 years
|
54.9 titers
Interval 48.7 to 61.9
|
51.9 titers
Interval 45.9 to 58.7
|
57.6 titers
Interval 50.9 to 65.1
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 3-8 years
|
481.3 titers
Interval 443.2 to 522.8
|
163.5 titers
Interval 148.4 to 180.1
|
566.7 titers
Interval 522.9 to 614.1
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 9-17 years
|
134.3 titers
Interval 115.2 to 156.5
|
149.3 titers
Interval 130.3 to 171.1
|
162.8 titers
Interval 140.4 to 188.6
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 9-17 years
|
748.1 titers
Interval 676.9 to 826.8
|
380.6 titers
Interval 342.1 to 423.4
|
797.9 titers
Interval 719.5 to 885.0
|
—
|
SECONDARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=234 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 18-35 months
|
10.8 titers
Interval 9.0 to 13.1
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 6-17 months
|
7.1 titers
Interval 5.5 to 9.1
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 6-17 months
|
56.2 titers
Interval 39.9 to 79.2
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 18-35 months
|
15.6 titers
Interval 12.3 to 19.8
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 18-35 months
|
208.3 titers
Interval 164.6 to 263.4
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 6-17 months
|
6.2 titers
Interval 5.1 to 7.6
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 6-17 months
|
43.8 titers
Interval 33.7 to 57.0
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 18-35 months
|
9.8 titers
Interval 8.1 to 11.9
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 18-35 months
|
118.2 titers
Interval 96.8 to 144.4
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 6-17 months
|
5.9 titers
Interval 5.3 to 6.6
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 6-17 months
|
40.2 titers
Interval 31.2 to 51.6
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 18-35 months
|
120.7 titers
Interval 98.2 to 148.4
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 6-17 months
|
10.0 titers
Interval 7.9 to 12.7
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 6-17 months
|
93.5 titers
Interval 73.5 to 119.0
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 18-35 months
|
14.8 titers
Interval 12.4 to 17.7
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 18-35 months
|
216.3 titers
Interval 180.9 to 258.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=790 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=818 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=800 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, 9-17 years
|
275 Participants
|
267 Participants
|
276 Participants
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, 3-8 years
|
364 Participants
|
367 Participants
|
154 Participants
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, 3-8 years
|
447 Participants
|
468 Participants
|
457 Participants
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, 3-8 years
|
367 Participants
|
365 Participants
|
376 Participants
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, 9-17 years
|
204 Participants
|
213 Participants
|
199 Participants
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, 9-17 years
|
189 Participants
|
193 Participants
|
83 Participants
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, 3-8 years
|
376 Participants
|
203 Participants
|
403 Participants
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, 9-17 years
|
197 Participants
|
100 Participants
|
163 Participants
|
—
|
SECONDARY outcome
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=232 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, 6-17 months
|
43 Participants
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, 18-35 months
|
138 Participants
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, 6-17 months
|
37 Participants
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, 18-35 months
|
122 Participants
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, 6-17 months
|
36 Participants
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, 18-35 months
|
122 Participants
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, 6-17 months
|
52 Participants
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, 18-35 months
|
139 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Outcome measures
| Measure |
GSK2321138A 1 Group
n=791 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=819 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=801 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=234 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
FLU A/Victoria/210/09, POST
|
775 Participants
|
800 Participants
|
773 Participants
|
169 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
FLU A/California/7/09, PRE
|
343 Participants
|
404 Participants
|
353 Participants
|
60 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
FLU A/California/7/09, POST
|
764 Participants
|
793 Participants
|
778 Participants
|
187 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
FLU A/Victoria/210/09, PRE
|
381 Participants
|
412 Participants
|
409 Participants
|
34 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
FLU B/Brisbane/60/08, PRE
|
381 Participants
|
396 Participants
|
399 Participants
|
28 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
FLU B/Brisbane/60/08, POST
|
770 Participants
|
790 Participants
|
639 Participants
|
167 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
FLU B/Brisbane/3/07, PRE
|
565 Participants
|
575 Participants
|
593 Participants
|
48 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
FLU B/Brisbane/3/07, POST
|
785 Participants
|
772 Participants
|
798 Participants
|
212 Participants
|
SECONDARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=791 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=819 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=801 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 3-8 years
|
206 Participants
|
234 Participants
|
230 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 3-8 years
|
217 Participants
|
218 Participants
|
232 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 9-17 years
|
164 Participants
|
178 Participants
|
167 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 3-8 years
|
469 Participants
|
491 Participants
|
487 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 9-17 years
|
137 Participants
|
170 Participants
|
123 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 9-17 years
|
295 Participants
|
302 Participants
|
291 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 3-8 years
|
253 Participants
|
277 Participants
|
269 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 3-8 years
|
477 Participants
|
496 Participants
|
481 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 9-17 years
|
128 Participants
|
135 Participants
|
140 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 9-17 years
|
298 Participants
|
304 Participants
|
292 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 3-8 years
|
478 Participants
|
489 Participants
|
378 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 9-17 years
|
292 Participants
|
301 Participants
|
261 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 3-8 years
|
315 Participants
|
309 Participants
|
329 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 3-8 years
|
485 Participants
|
465 Participants
|
503 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 9-17 years
|
250 Participants
|
266 Participants
|
264 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 9-17 years
|
300 Participants
|
307 Participants
|
295 Participants
|
—
|
SECONDARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=234 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 18-35 months
|
130 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 18-35 months
|
37 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 6-17 months
|
6 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 6-17 months
|
45 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 18-35 months
|
54 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 18-35 months
|
142 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 6-17 months
|
4 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 6-17 months
|
39 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 18-35 months
|
30 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 6-17 months
|
1 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 6-17 months
|
38 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 18-35 months
|
27 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 18-35 months
|
129 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 6-17 months
|
11 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 6-17 months
|
61 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 18-35 months
|
151 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Outcome measures
| Measure |
GSK2321138A 1 Group
n=791 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=819 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=801 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=234 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza.
FLU A/California/7/09, POST
|
732 Participants
|
763 Participants
|
744 Participants
|
155 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza.
FLU B/Brisbane/3/07, PRE
|
454 Participants
|
462 Participants
|
476 Participants
|
24 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza.
FLU B/Brisbane/3/07, POST
|
779 Participants
|
692 Participants
|
784 Participants
|
175 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza.
FLU A/California/7/09, PRE
|
201 Participants
|
218 Participants
|
202 Participants
|
49 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza.
FLU A/Victoria/210/09, PRE
|
228 Participants
|
245 Participants
|
267 Participants
|
27 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza.
FLU A/Victoria/210/09, POST
|
721 Participants
|
748 Participants
|
721 Participants
|
125 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza.
FLU B/Brisbane/60/08, PRE
|
244 Participants
|
258 Participants
|
269 Participants
|
18 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza.
FLU B/Brisbane/60/08, POST
|
708 Participants
|
733 Participants
|
488 Participants
|
140 Participants
|
SECONDARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=791 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=819 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=801 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 3-8 years
|
453 Participants
|
471 Participants
|
464 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 3-8 years
|
145 Participants
|
140 Participants
|
150 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 3-8 years
|
480 Participants
|
395 Participants
|
493 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 3-8 years
|
130 Participants
|
128 Participants
|
141 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 9-17 years
|
71 Participants
|
90 Participants
|
61 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 9-17 years
|
279 Participants
|
292 Participants
|
280 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 3-8 years
|
156 Participants
|
177 Participants
|
190 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 3-8 years
|
446 Participants
|
462 Participants
|
446 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 9-17 years
|
72 Participants
|
68 Participants
|
77 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 9-17 years
|
275 Participants
|
286 Participants
|
275 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 3-8 years
|
430 Participants
|
441 Participants
|
286 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 9-17 years
|
99 Participants
|
118 Participants
|
119 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 9-17 years
|
278 Participants
|
292 Participants
|
202 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 3-8 years
|
233 Participants
|
227 Participants
|
248 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 9-17 years
|
221 Participants
|
235 Participants
|
228 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 9-17 years
|
299 Participants
|
297 Participants
|
291 Participants
|
—
|
SECONDARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=234 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, PRE, 6-17 months
|
6 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, POST, 6-17 months
|
31 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, PRE, 18-35 months
|
43 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, POST, 18-35 months
|
124 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, PRE, 6-17 months
|
4 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, POST, 6-17 months
|
18 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, PRE, 18-35 months
|
23 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, POST, 18-35 months
|
107 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, PRE, 6-17 months
|
0 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, POST, 6-17 months
|
25 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, PRE, 18-35 months
|
18 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, POST, 18-35 months
|
115 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, PRE, 6-17 months
|
4 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, POST, 6-17 months
|
43 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, PRE, 18-35 months
|
20 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, POST, 18-35 months
|
132 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Outcome measures
| Measure |
GSK2321138A 1 Group
n=791 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=819 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=801 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=234 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
FLU A/Victoria/210/09, PRE
|
103 Participants
|
124 Participants
|
121 Participants
|
15 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
FLU B/Brisbane/60/08, PRE
|
123 Participants
|
126 Participants
|
148 Participants
|
9 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
FLU B/Brisbane/3/07, POST
|
730 Participants
|
564 Participants
|
756 Participants
|
129 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
FLU A/California/7/09, PRE
|
71 Participants
|
92 Participants
|
79 Participants
|
28 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
FLU A/California/7/09, POST
|
669 Participants
|
720 Participants
|
690 Participants
|
122 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
FLU A/Victoria/210/09, POST
|
597 Participants
|
597 Participants
|
599 Participants
|
82 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
FLU B/Brisbane/60/08, POST
|
578 Participants
|
607 Participants
|
300 Participants
|
83 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
FLU B/Brisbane/3/07, PRE
|
300 Participants
|
324 Participants
|
327 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=791 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=819 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=801 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 9-17 years
|
24 Participants
|
36 Participants
|
22 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 3-8 years
|
380 Participants
|
385 Participants
|
390 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, POST, 9-17 years
|
217 Participants
|
212 Participants
|
209 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, PRE, 3-8 years
|
47 Participants
|
56 Participants
|
57 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 3-8 years
|
410 Participants
|
442 Participants
|
428 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Cal/7/09, POST, 9-17 years
|
259 Participants
|
278 Participants
|
262 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 3-8 years
|
70 Participants
|
92 Participants
|
87 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Vic/210/09, PRE, 9-17 years
|
33 Participants
|
32 Participants
|
34 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 3-8 years
|
75 Participants
|
66 Participants
|
82 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 3-8 years
|
349 Participants
|
357 Participants
|
174 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, PRE, 9-17 years
|
48 Participants
|
60 Participants
|
66 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/60/08, POST, 9-17 years
|
229 Participants
|
250 Participants
|
126 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 3-8 years
|
135 Participants
|
155 Participants
|
150 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 3-8 years
|
444 Participants
|
301 Participants
|
473 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, PRE, 9-17 years
|
165 Participants
|
169 Participants
|
177 Participants
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Bri/3/07, POST, 9-17 years
|
286 Participants
|
263 Participants
|
283 Participants
|
—
|
SECONDARY outcome
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=234 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, PRE, 6-17 months
|
3 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, POST, 6-17 months
|
11 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, PRE, 18-35 months
|
12 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, POST, 18-35 months
|
71 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, PRE, 6-17 months
|
0 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, POST, 6-17 months
|
7 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, PRE, 18-35 months
|
9 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, POST, 18-35 months
|
76 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, PRE, 6-17 months
|
1 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, POST, 6-17 months
|
25 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, PRE, 18-35 months
|
6 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, POST, 18-35 months
|
104 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, PRE, 6-17 months
|
5 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, POST, 6-17 months
|
18 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, PRE, 18-35 months
|
23 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, POST, 18-35 months
|
104 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Outcome measures
| Measure |
GSK2321138A 1 Group
n=790 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=818 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=800 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=232 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU B/Brisbane/3/07
|
7.4 fold change
Interval 6.8 to 8.0
|
2.9 fold change
Interval 2.7 to 3.1
|
7.6 fold change
Interval 7.0 to 8.3
|
12.9 fold change
Interval 11.0 to 15.3
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU A/California/7/09
|
18.0 fold change
Interval 16.6 to 19.5
|
17.4 fold change
Interval 16.0 to 18.8
|
19.2 fold change
Interval 17.7 to 20.9
|
11.7 fold change
Interval 10.2 to 13.4
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU A/Victoria/210/09
|
7.9 fold change
Interval 7.3 to 8.6
|
7.2 fold change
Interval 6.7 to 7.8
|
7.5 fold change
Interval 6.9 to 8.1
|
10.4 fold change
Interval 9.0 to 11.9
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLU B/Brisbane/60/08
|
7.9 fold change
Interval 7.3 to 8.6
|
7.9 fold change
Interval 7.2 to 8.6
|
2.7 fold change
Interval 2.5 to 2.9
|
9.7 fold change
Interval 8.5 to 11.2
|
SECONDARY outcome
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=790 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=818 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=800 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, 3-8 years
|
17.2 fold change
Interval 15.6 to 19.0
|
17.2 fold change
Interval 15.6 to 18.9
|
17.2 fold change
Interval 15.6 to 18.9
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, 9-17 years
|
19.2 fold change
Interval 16.7 to 22.2
|
17.7 fold change
Interval 15.2 to 20.5
|
23.3 fold change
Interval 20.3 to 26.9
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, 3-8 years
|
8.4 fold change
Interval 7.6 to 9.3
|
7.3 fold change
Interval 6.6 to 8.1
|
7.8 fold change
Interval 7.1 to 8.5
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, 9-17 years
|
7.2 fold change
Interval 6.2 to 8.2
|
7.1 fold change
Interval 6.2 to 8.1
|
7.1 fold change
Interval 6.2 to 8.1
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, 3-8 years
|
8.8 fold change
Interval 7.9 to 9.8
|
8.8 fold change
Interval 7.9 to 9.8
|
2.8 fold change
Interval 2.6 to 3.1
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, 9-17 years
|
6.7 fold change
Interval 5.8 to 7.8
|
6.6 fold change
Interval 5.7 to 7.6
|
2.4 fold change
Interval 2.1 to 2.7
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, 3-8 years
|
8.8 fold change
Interval 7.9 to 9.8
|
3.1 fold change
Interval 2.9 to 3.4
|
9.9 fold change
Interval 8.9 to 11.0
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, 9-17 years
|
5.6 fold change
Interval 4.9 to 6.3
|
2.5 fold change
Interval 2.3 to 2.8
|
4.9 fold change
Interval 4.3 to 5.6
|
—
|
SECONDARY outcome
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=232 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, 6-17 months
|
8.2 fold change
Interval 6.4 to 10.6
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/California/7/09, 18-35 months
|
13.7 fold change
Interval 11.7 to 16.0
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, 6-17 months
|
7.3 fold change
Interval 5.9 to 9.0
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU A/Victoria/210/09, 18-35 months
|
12.1 fold change
Interval 10.2 to 14.3
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, 6-17 months
|
6.9 fold change
Interval 5.4 to 8.9
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/60/08, 18-35 months
|
11.3 fold change
Interval 9.6 to 13.2
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, 6-17 months
|
9.5 fold change
Interval 7.0 to 12.8
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
FLU B/Brisbane/3/07, 18-35 months
|
14.8 fold change
Interval 12.2 to 18.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination.Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom completed.
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful (Child \<6 years) or pain that prevented normal activity (Child \>6 years). Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of the injection site.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=903 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=902 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=906 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=277 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Pain
|
444 Participants
|
425 Participants
|
416 Participants
|
116 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain
|
20 Participants
|
21 Participants
|
13 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Redness
|
225 Participants
|
214 Participants
|
206 Participants
|
100 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Redness
|
12 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Swelling
|
196 Participants
|
193 Participants
|
160 Participants
|
67 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Swelling
|
11 Participants
|
10 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination.Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature \>39.0°C.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=291 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=314 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=280 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=277 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Any Drowsiness
|
67 Participants
|
55 Participants
|
59 Participants
|
84 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Grade 3 Drowsiness
|
5 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Related Drowsiness
|
44 Participants
|
31 Participants
|
36 Participants
|
57 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Any Irritability
|
65 Participants
|
56 Participants
|
53 Participants
|
119 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Grade 3 Irritability
|
4 Participants
|
2 Participants
|
3 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Related Irritability
|
44 Participants
|
37 Participants
|
31 Participants
|
81 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Any Loss of appetite
|
59 Participants
|
40 Participants
|
47 Participants
|
83 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Grade 3 Loss of appetite
|
3 Participants
|
3 Participants
|
3 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Related Loss of appetite
|
37 Participants
|
24 Participants
|
25 Participants
|
50 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Temperature ≥37.5°C
|
50 Participants
|
51 Participants
|
41 Participants
|
81 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Temperature >39°C
|
4 Participants
|
2 Participants
|
3 Participants
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Related Temperature
|
24 Participants
|
29 Participants
|
16 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination.Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature \>39.0°C.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=613 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=589 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=626 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Any Fatigue
|
129 Participants
|
118 Participants
|
114 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Grade 3 Fatigue
|
9 Participants
|
8 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Related Fatigue
|
95 Participants
|
81 Participants
|
76 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Any Gastro.
|
66 Participants
|
62 Participants
|
52 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Grade 3 Gastro.
|
7 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Related Gastro.
|
31 Participants
|
29 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Any Headache
|
110 Participants
|
125 Participants
|
114 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Grade 3 Headache
|
8 Participants
|
4 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Related Headache
|
66 Participants
|
75 Participants
|
71 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Any Joint Pain
|
69 Participants
|
63 Participants
|
51 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Grade 3 Joint Pain
|
2 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Related Joint Pain
|
44 Participants
|
43 Participants
|
36 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Any Muscle aches
|
116 Participants
|
106 Participants
|
106 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Grade 3 Muscle aches
|
4 Participants
|
8 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Related Muscle aches
|
84 Participants
|
81 Participants
|
87 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Any Shivering
|
44 Participants
|
31 Participants
|
37 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Grade 3 Shivering
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Related Shivering
|
27 Participants
|
23 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Temperature ≥37.5°C
|
48 Participants
|
60 Participants
|
47 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Temperature >39°C
|
7 Participants
|
5 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Related Temperature
|
25 Participants
|
30 Participants
|
32 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 28-day (Days 0-27) follow-up period after any vaccination.Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=915 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=912 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=911 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=277 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with any AE(s)
|
284 Participants
|
305 Participants
|
308 Participants
|
167 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with grade 3 AE(s)
|
20 Participants
|
37 Participants
|
26 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with related AE(s)
|
18 Participants
|
19 Participants
|
23 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 - Day 180)Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.
MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = any MAE regardless of intensity or relationship to vaccination. Grade 3 MAE = MAE which prevented normal, everyday activities. Related = MAE assessed by the investigator as related to the vaccination. Assessment of intensity for MAEs was not performed.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=915 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=912 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=911 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=277 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Subjects with any MAE(s)
|
271 Participants
|
278 Participants
|
303 Participants
|
171 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Subjects with related MAE(s)
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Subjects with Grade 3 MAE(s)
|
NA Participants
Analysis was not performed.
|
NA Participants
Analysis was not performed.
|
NA Participants
Analysis was not performed.
|
NA Participants
Analysis was not performed.
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 - Day 180)Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results
pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=915 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=912 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=911 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=277 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).
Subjects with related pIMD(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).
Subjects with any pIMD(s)
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 - Day 180)Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=915 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=912 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=911 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=277 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Subjects with any SAE(s)
|
8 Participants
|
6 Participants
|
7 Participants
|
9 Participants
|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Subjects with related SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination.Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited local symptoms for duration were pain, redness and swelling at the injection site.
Outcome measures
| Measure |
GSK2321138A 1 Group
n=395 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=382 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=365 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=94 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Days With Solicited Local Symptoms.
Swelling, Dose 2
|
2.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 4.0
|
|
Number of Days With Solicited Local Symptoms.
Pain, Dose 1
|
2.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
1.0 days
Interval 1.0 to 2.0
|
|
Number of Days With Solicited Local Symptoms.
Pain, Dose 2
|
2.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 2.0
|
|
Number of Days With Solicited Local Symptoms.
Redness, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.5 to 4.0
|
|
Number of Days With Solicited Local Symptoms.
Redness, Dose 2
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
|
Number of Days With Solicited Local Symptoms.
Swelling, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination.Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited general symptoms for duration were drowsiness, fatigue, gastrointestinal symptoms (Gastro.), headache, irritability, loss of appetite, muscle aches, shivering and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\].
Outcome measures
| Measure |
GSK2321138A 1 Group
n=121 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=113 Participants
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=99 Participants
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=79 Participants
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Number of Days With Solicited General Symptoms
Drowsiness, Dose 1
|
1.0 days
Interval 1.0 to 2.0
|
1.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 3.0
|
1.0 days
Interval 1.0 to 3.0
|
|
Number of Days With Solicited General Symptoms
Drowsiness, Dose 2
|
2.0 days
Interval 1.0 to 3.0
|
1.0 days
Interval 1.0 to 2.0
|
1.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 3.0
|
|
Number of Days With Solicited General Symptoms
Fatigue, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Fatigue, Dose 2
|
1.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 2.0
|
1.0 days
Interval 1.0 to 2.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Gastro., Dose 1
|
1.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 2.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Gastro., Dose 2
|
1.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 2.0
|
1.0 days
Interval 1.0 to 2.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Headache, Dose 1
|
1.0 days
Interval 1.0 to 2.5
|
1.0 days
Interval 1.0 to 2.0
|
1.0 days
Interval 1.0 to 2.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Headache, Dose 2
|
1.0 days
Interval 1.0 to 2.0
|
1.0 days
Interval 1.0 to 2.0
|
1.0 days
Interval 1.0 to 2.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Irritability, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
|
Number of Days With Solicited General Symptoms
Irritability, Dose 2
|
2.0 days
Interval 1.0 to 3.0
|
1.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
|
Number of Days With Solicited General Symptoms
Joint pain, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 2.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Joint pain, Dose 2
|
1.0 days
Interval 1.0 to 2.0
|
1.0 days
Interval 1.0 to 2.0
|
1.5 days
Interval 1.0 to 2.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Loss of appetite, Dose 1
|
1.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 4.0
|
3.0 days
Interval 1.0 to 4.5
|
|
Number of Days With Solicited General Symptoms
Loss of appetite, Dose 2
|
3.0 days
Interval 1.0 to 4.0
|
1.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 2.0
|
3.0 days
Interval 2.0 to 4.0
|
|
Number of Days With Solicited General Symptoms
Muscle aches, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 2.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Muscle aches, Dose 2
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 2.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Shivering, Dose 1
|
1.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 5.0
|
1.0 days
Interval 1.0 to 2.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Shivering, Dose 2
|
1.0 days
Interval 1.0 to 3.0
|
1.5 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 2.0
|
NA days
Symptom not assessed in this group.
|
|
Number of Days With Solicited General Symptoms
Temperature, Dose 1
|
1.0 days
Interval 1.0 to 2.0
|
1.5 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
1.0 days
Interval 1.0 to 2.0
|
|
Number of Days With Solicited General Symptoms
Temperature, Dose 2
|
1.5 days
Interval 1.0 to 2.0
|
1.5 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
Adverse Events
GSK2321138A 1 Group
Serious events: 8 serious events
Other events: 630 other events
Deaths: 0 deaths
Fluarix Group
Serious events: 6 serious events
Other events: 616 other events
Deaths: 0 deaths
GSK2604409A Group
Serious events: 7 serious events
Other events: 620 other events
Deaths: 0 deaths
GSK2321138A 2 Group
Serious events: 9 serious events
Other events: 237 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK2321138A 1 Group
n=915 participants at risk
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=912 participants at risk
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=911 participants at risk
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=277 participants at risk
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.11%
1/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.11%
1/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Cardiac disorders
Myocarditis
|
0.11%
1/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.36%
1/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.11%
1/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.36%
1/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
1.1%
3/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.72%
2/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.22%
2/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.72%
2/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.11%
1/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.11%
1/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.36%
1/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Infectious mononucleosis
|
0.11%
1/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Otitis media acute
|
0.11%
1/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Peritonsillar abscess
|
0.11%
1/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.36%
1/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.22%
2/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.36%
1/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Tonsillitis
|
0.11%
1/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.36%
1/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.11%
1/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.33%
3/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.22%
2/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.11%
1/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.11%
1/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.11%
1/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.36%
1/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.72%
2/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Psychiatric disorders
Suicidal ideation
|
0.11%
1/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.11%
1/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.11%
1/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.11%
1/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
Other adverse events
| Measure |
GSK2321138A 1 Group
n=915 participants at risk
Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
Fluarix Group
n=912 participants at risk
Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2604409A Group
n=911 participants at risk
Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
GSK2321138A 2 Group
n=277 participants at risk
Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.4%
49/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
6.6%
60/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
7.0%
64/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
13.4%
37/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
48/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
5.6%
51/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
5.0%
46/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
9.4%
26/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
40/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
3.9%
36/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
4.9%
45/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
7.6%
21/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Pyrexia
|
2.5%
23/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
2.5%
23/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
3.1%
28/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
6.5%
18/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
Infections and infestations
Bronchitis
|
1.4%
13/915 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.55%
5/912 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
1.3%
12/911 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
10.5%
29/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Fatigue
|
21.0%
129/613 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
20.0%
118/589 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
18.2%
114/626 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Gastrointestinal
|
10.8%
66/613 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
10.5%
62/589 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
8.3%
52/626 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Headache
|
17.9%
110/613 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
21.2%
125/589 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
18.2%
114/626 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Joint Pain
|
11.3%
69/613 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
10.7%
63/589 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
8.1%
51/626 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Muscle aches
|
18.9%
116/613 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
18.0%
106/589 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
16.9%
106/626 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Temperature (Axillary)
|
17.2%
50/291 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
16.2%
51/314 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
14.6%
41/280 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
29.2%
81/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Irritability
|
22.3%
65/291 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
17.8%
56/314 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
18.9%
53/280 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
43.0%
119/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Drowsiness
|
23.0%
67/291 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
17.5%
55/314 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
21.1%
59/280 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
30.3%
84/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Loss of appetite
|
20.3%
59/291 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
12.7%
40/314 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
16.8%
47/280 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
30.0%
83/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Pain
|
49.2%
444/903 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
47.1%
425/902 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
45.9%
416/906 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
41.9%
116/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Redness
|
24.9%
225/903 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
23.7%
214/902 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
22.7%
206/906 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
36.1%
100/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Swelling
|
21.7%
196/903 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
21.4%
193/902 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
17.7%
160/906 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
24.2%
67/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
|
General disorders
Shivering
|
7.2%
44/613 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
5.3%
31/589 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
5.9%
37/626 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
0.00%
0/277 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.
No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER